Early Rheumatoid ArthritisNCT04752748
Power Doppler in Hand Joints of Early RA Patients
An observational study of Early Rheumatoid Arthritis, run by Federal University of São Paulo.
Trial summary
It is a prospective case-control study with women diagnosed early rheumatoid arthritis. Three therapeutic failures were considered: failure 1 - to the first Disease-modifying antirheumatic drugs (DMARDs) (methotrexate); failure 2 - to the second DMARDs (leflunomide) and failure 3 - to the first immunobiological drugs… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Early Rheumatoid Arthritis
- What is being tested?
- Drug protocol
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Woman diagnosed eith early rheumatoid arthritis naive for treatment
Who may be able to join
- early rheumatoid arthritis fulfilment of the 2010 ACR/EULAR RA classification criteria;
- age between 18-65 years;
- female gender,
- naive for treatment.
Who cannot join
- use of oral > 10 mg/d glucocorticoid in the previous three weeks;
- serum aspartate aminotransferase or alanine aminotransferase level > 3 times the upper limit of normal;
- bone marrow, auto-imune, lymphoproliferative or infectious diseases;
- pregnancy.
About this study
Official title: Power Doppler in Hand Joints is a Predictor of Therapeutic Failure in Women With Early Rheumatoid Arthritis Naive for Treatment
It is a prospective case-control study with women diagnosed early rheumatoid arthritis. Three therapeutic failures were considered: failure 1 - to the first Disease-modifying antirheumatic drugs (DMARDs) (methotrexate); failure 2 - to the second DMARDs (leflunomide) and failure 3 - to the first immunobiological drugs (adalimumab). Ultrasound was performed bilaterally on the 2nd and 3rd metacarpophalangeal joints (MCFs), proximal interphalangeal joints (IFPs), and wrists (US10). Ultrasound measurements (qualitative and semi-quantitative) evaluated: 1 - inflammatory: synovial and tenosynovial proliferation in gray scale and power Doppler (0-3); 2 - joint damage: bone erosion (qualitative and semi-quantitative) and cartilage damage (qualitative and semi-quantitative). Clinical and laboratory variables were also assessed blindly at baseline and after 12, 24 e 48 weeks.
- Conditions
- Early Rheumatoid Arthritis
- Being tested
- Drug protocol
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug protocolDrug
The following drug scheme was carried out: The patients began with methotrexate (MTX) 15 mg / week, which was increased to 25 mg / week until week 12. Subsequent steps for patients with an insufficient response (DAS28 score> 3.2 and the Physician's Global Assessment (PGA)> 4.0 [0-10 cm]) were leflunomide 20mg / day with MTX 15 mg / week from week 12 to week 24 and adalimumab twice a month and MTX 15mg / week from week 24 to week 48. The use of 5mg folic acid was advised once a week during the 48 weeks of the study. Three treatment failures were considered over these 48 weeks:
- Failure 1: failure of the first DMARD (MTX) in week 12.
- Failure 2: failure of the second DMARD (leflunomide) at week 24
- Failure 3: failure of the first immunobiological (adalimumab) at week 48.
| Study group | Role | What they receive |
|---|---|---|
| Woman with Early Rheumatoid Arthritis | Not described Receives: Drug: Drug protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Synovial blood flow (power doppler)
Measured in ultrasound examination
Measured: Baseline, after 4, 12, 24 and 48 weeks
Secondary outcomes (8)
Change in Synovial Proliferation
Measured in ultrasound examination
Measured: Baseline, after 4, 12, 24 and 48 weeks
Changes in Tenosynovitis
Measured in ultrasound examination
Measured: Baseline, after 4, 12, 24 and 48 weeks
Changes in Joint Damage
Measured in ultrasound examination
Measured: Baseline, after 4, 12, 24 and 48 weeks
Changes in C-reactive protein level (mg/liter)
Measured in blood test
Measured: Baseline, after 4, 12, 24 and 48 weeks
Changes in erythrocyte sedimentation rate level (mm/hour)
Measured in blood test
Measured: Baseline, after 4, 12, 24 and 48 weeks
Changes in function
Measured by Health Assessment Questionnaire
Measured: Baseline, after 4, 12, 24 and 48 weeks
Changes in upper limb function
Measured by Disabilities of the Arm, Shoulder and Hand Questionnaire
Measured: Baseline, after 4, 12, 24 and 48 weeks
Changes in disease activity score
Measured by disease activity score 28
Measured: Baseline, after 4, 12, 24 and 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study startAug 2014
- Primary completionAug 2015
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Early Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karine Rodrigues da Luz, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04752748
- Sponsor's protocol ID
- 106108
- Status last verified
- Feb 2021
- First submitted
- 10 Feb 2021
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
da Luz KR, Natour J, Pinheiro MM, Petterle GS, Dos Santos MF, Fernandes ADRC, Furtado RNV. Power Doppler in hand joints predicts therapeutic failure in treatment-naive women with early rheumatoid arthritis: A prospective study. Clinics (Sao Paulo). 2025 Mar 1;80:100593. doi: 10.1016/j.clinsp.2025.100593. eCollection 2025.
PubMed 40023888
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Power Doppler in Hand Joints is a Predictor of Therapeutic Failure in Women With Early Rheumatoid Arthritis Naive for Treatment
- ClinicalTrials.gov ID
- NCT04752748
- Acronym / sponsor ID
- 106108
- Conditions
- Early Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 12 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is a prospective case-control study with women diagnosed early rheumatoid arthritis. Three therapeutic failures were considered: failure 1 - to the first Disease-modifying antirheumatic drugs (DMARDs) (methotrexate); failure 2 - to the second DMARDs (leflunomide) and failure 3 - to the first immunobiological drugs (adalimumab). Ultrasound was performed bilaterally on the 2nd and 3rd metacarpophalangeal joints (MCFs), proximal interphalangeal joints (IFPs), and wrists (US10). Ultrasound measurements (qualitative and semi-quantitative) evaluated: 1 - inflammatory: synovial and tenosynovial proliferation in gray scale and power Doppler (0-3); 2 - joint damage: bone erosion (qualitative and semi-quantitative) and cartilage damage (qualitative and semi-quantitative). Clinical and laboratory variables were also assessed blindly at baseline and after 12, 24 e 48 weeks.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Woman with Early Rheumatoid Arthritis | – | Drug: Drug protocol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Woman diagnosed eith early rheumatoid arthritis naive for treatment
Key inclusion criteria (4 listed)
- early rheumatoid arthritis fulfilment of the 2010 ACR/EULAR RA classification criteria;
- age between 18-65 years;
- female gender,
- naive for treatment.
Key exclusion criteria (4 listed)
- use of oral > 10 mg/d glucocorticoid in the previous three weeks;
- serum aspartate aminotransferase or alanine aminotransferase level > 3 times the upper limit of normal;
- bone marrow, auto-imune, lymphoproliferative or infectious diseases;
- pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug protocolThe following drug scheme was carried out: The patients began with methotrexate (MTX) 15 mg / week, which was increased to 25 mg / week until week 12. Subsequent steps for patients with an insufficient response (DAS28 score> 3.2 and the Physician's Global Assessment (PGA)> 4.0 [0-10 cm]) were leflunomide 20mg / day with MTX 15 mg / week from week 12 to week 24 and adalimumab twice a month and MTX 15mg / week from week 24 to week 48. The use of 5mg folic acid was advised once a week during the 48 weeks of the study. Three treatment failures were considered over these 48 weeks: * Failure 1: failure of the first DMARD (MTX) in week 12. * Failure 2: failure of the second DMARD (leflunomide) at week 24 * Failure 3: failure of the first immunobiological (adalimumab) at week 48. | Drug | Woman with Early Rheumatoid Arthritis |
Primary outcome
Changes in Synovial blood flow (power doppler)
Time frame: Baseline, after 4, 12, 24 and 48 weeks
Measured in ultrasound examination
8 secondary outcomes
Change in Synovial Proliferation
Time frame: Baseline, after 4, 12, 24 and 48 weeks
Changes in Tenosynovitis
Time frame: Baseline, after 4, 12, 24 and 48 weeks
Changes in Joint Damage
Time frame: Baseline, after 4, 12, 24 and 48 weeks
Changes in C-reactive protein level (mg/liter)
Time frame: Baseline, after 4, 12, 24 and 48 weeks
Changes in erythrocyte sedimentation rate level (mm/hour)
Time frame: Baseline, after 4, 12, 24 and 48 weeks
Changes in function
Time frame: Baseline, after 4, 12, 24 and 48 weeks
Changes in upper limb function
Time frame: Baseline, after 4, 12, 24 and 48 weeks
Changes in disease activity score
Time frame: Baseline, after 4, 12, 24 and 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Derived from this study: PubMed 40023888da Luz KR, Natour J, Pinheiro MM, Petterle GS, Dos Santos MF, Fernandes ADRC, Furtado RNV. Power Doppler in hand joints predicts therapeutic failure in treatment-naive women with early rheumatoid arthritis: A prospective study. Clinics (Sao Paulo). 2025 Mar 1;80:100593. doi: 10.1016/j.clinsp.2025.100593. eCollection 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Rheumatoid Arthritis, run by Federal University of São Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Synovial blood flow (power doppler) (time frame: Baseline, after 4, 12, 24 and 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04752748, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2021.